MAUDE Adverse Event Report: BIOMET SPAIN, S.L. RINGLOC MODULAR ACETABULAR SYSTEM (SPIDERCUP, RIMCUP, BATCUP); PROSTHESIS, HIP

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Although there is a lack of information, the nature of the incidences gathered on this complaint complies with cfr 21 - part 803 medical device reporting subpart e¿manufacturer reporting requirements 803.50.Complete information regarding this event has not been received.This event is being notified based on the statement ¿pre-disposition to report rather than not to report in case of doubt¿ this product is manufactured by biomet (b)(4).And is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states under 510(k) number k121874.

Event Description

During the performance of the schedule pms survey hip - modular cup system# 19 rev.3, the survey performed by dr (b)(6), of (b)(6) hosp reveals some issues (implant revision due to loosening; post-operative complications due to deep infection > 3 months and dislocation) that should be managed through the complaint handling system.Complete information regarding this event has not been received.

• Brand Name: RINGLOC MODULAR ACETABULAR SYSTEM (SPIDERCUP, RIMCUP, BATCUP)
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET SPAIN, S.L.; calle islas baleares, #50; p.o. box 96; fuente del jarro, valencia 46988 ; SP 46988
• Manufacturer (Section G): BIOMET SPAIN, S.L.; calle islas baleares, #50; p.o. box 96; fuente del jarro, valencia 46988 ; SP 46988
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7925125
• MDR Text Key: 122300728
• Report Number: 0009610576-2018-00033
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: PSEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1